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    Project Manager - New Brunswick, NJ, United States - KLNtek

    KLNtek
    KLNtek New Brunswick, NJ, United States

    1 week ago

    Default job background
    Technology / Internet
    Description

    Summary:

    The End-to-End Project Manager (E2E PM) will lead several new Abbreviated New Drug Application (ANDA) project launch teams, starting with developing a regulatory filing strategy through the commercialization of products following FDA approval. The E2E PM will work closely with technical, medical, and regulatory subject matter experts to develop project plans and monitor project execution.

    Key Responsibilities:

    • Responsible for leading cross-functional ANDA projects, including planning, tracking, acceleration, risk identification, and mitigation. Owns development and execution of project reviews, including scenario development, trade-off implications and the evaluation/assessment of improvement opportunities
    • Assemble and maintain an integrated project timeline of all ANDA and ANDA-enabling activities
    • Facilitate Core Team Meetings
      • Maintain project 1-pager denoting workstream status (On Track, At Risk, Off Track, etc.), key upcoming deliverables and key risks
    • Monitors and supervises action items and plans to ensure rapid follow-through and progress against commitments, including develop of a detailed project plan to monitor and track progress
    • Provide project updates on a consistent basis to various stakeholders about strategy, adjustments, and progress
    • Create and maintain comprehensive project documentation

    Qualifications:

    • Minimum 6 years of relevant work experience within the healthcare (i.e. Pharmaceuticals or Medical Technology) industry
    • Project Management experience, including developing and implementing processes for new or existing products
    • Demonstrated ability applying project management methodologies and tools, resource management practices, budget management, and organizational change techniques
    • Outstanding communication and interpersonal skills (written, presentation, meeting management, documentation) to effectively persuade and work across segments and functions at all levels of the organization
    • Experience with Abbreviated New Drug Applications (ANDA) and/or generic pharmaceutical experience strongly preferred
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